Note: Descriptions are shown in the official language in which they were submitted.
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PORTABLE AIR PULSATOR AND THORACIC THERAPY GARMENT
FIELD OF THE INVENTION
[0001] The invention relates to a portable medical device operable with a
thoracic therapy
garment to apply repetitive compression forces to the body of a person to aid
blood
circulation, loosen and eliminate mucus from the lungs and trachea and relieve
muscular and
nerve tensions.
BACKGROUND OF THE INVENTION
[0002] Clearance of mucus from the respiratory tract in healthy individuals is
accomplished
primarily by the body's normal mucociliary action and cough. Under normal
conditions these
mechanisms are very efficient. Impairment of the normal mucociliary transport
system or
hypersecretion of respiratory mucus results in an accumulation of mucus and
debris in the
lungs and can cause severe medical complications such as hypoxemia,
hypercapnia, chronic
bronchitis and pneumonia. These complications can result in a diminished
quality of life or
even become a cause of death. Abnormal respiratory mucus clearance is a
manifestation of
many medical conditions such as pertussis, cystic fibrosis, atelectasis,
bronchiectasis,
cavitating lung disease, vitamin A deficiency, chronic obstructive pulmonary
disease, asthma,
and immotile cilia syndrome. Exposure to cigarette smoke, air pollutants and
viral infections
also adversely affect mucociliary function. Post surgical patients, paralyzed
persons, and
newborns with respiratory distress syndrome also exhibit reduced mucociliary
transport.
[0003] Chest physiotherapy has had a long history of clinical efficacy and is
typically a part
of standard medical regimens to enhance respiratory mucus transport. Chest
physiotherapy
can include mechanical manipulation of the chest, postural drainage with
vibration, directed
cough, active cycle of breathing and autogenic drainage. External manipulation
of the chest
and respiratory behavioral training are accepted practices. The various
methods of chest
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physiotherapy to enhance mucus clearance are frequently combined for optimal
efficacy and
are prescriptively individualized for each patient by the attending physician.
[0004] Cystic fibrosis (CF) is the most common inherited life-threatening
genetic disease
among Caucasians. The genetic defect disrupts chloride transfer in and out of
cells, causing
the normal mucus from the exocrine glands to become very thick and sticky,
eventually
blocking ducts of the glands in the pancreas, lungs and liver. Disruption of
the pancreatic
glands prevents secretion of important digestive enzymes and causes intestinal
problems that
can lead to malnutrition. In addition, the thick mucus accumulates in the
lung's respiratory
tracts, causing chronic infections, scarring, and decreased vital capacity.
Normal coughing is
not sufficient to dislodge these mucus deposits. CF usually appears during the
first 10 years
of life, often in infancy. Until recently, children with CF were not expected
to live into their
teens. However, with advances in digestive enzyme supplementation, anti-
inflammatory
therapy, chest physical therapy, and antibiotics, the median life expectancy
has increased to
30 years with some patients living into their 50s and beyond. CF is inherited
through a
recessive gene, meaning that if both parents carry the gene, there is a 25
percent chance that
an offspring will have the disease, a 50 percent chance they will be a carrier
and a 25 percent
chance they will be genetically unaffected. Some individuals who inherit
mutated genes from
both parents do not develop the disease. The normal progression of CF includes
gastrointestinal problems, failure to thrive, repeated and multiple lung
infections, and death
due to respiratory insufficiency. While some patients experience grave
gastrointestinal
symptoms, the majority of CF patients (90 percent) ultimately succumb to
respiratory
problems.
[0005] Virtually all patients with CF require respiratory therapy as a daily
part of their care
regimen. The buildup of thick, sticky mucus in the lungs clogs airways and
traps bacteria,
providing an ideal environment for respiratory infections and chronic
inflammation. This
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inflammation causes permanent scarring of the lung tissue, reducing the
capacity of the lungs
to absorb oxygen and, ultimately, sustain life. Respiratory therapy must be
performed, even
when the patient is feeling well, to prevent infections and maintain vital
capacity.
Traditionally, care providers perform Chest Physical Therapy (CPT) one to four
times per
day. CPT consists of a patient lying in one of twelve positions while a
caregiver "claps" or
pounds on the chest and back over each lobe of the lung. To treat all areas of
the lung in all
twelve positions requires pounding for half to three-quarters of an hour along
with inhalation
therapy. CPT clears the mucus by shaking loose airway secretions through chest
percussions
and draining the loosened mucus toward the mouth. Active coughing is required
to
ultimately remove the loosened mucus. CPT requires the assistance of a
caregiver, often a
family member but a nurse or respiratory therapist if one is not available. It
is a physically
exhausting process for both the CF patient and the caregiver. Patient and
caregiver non-
compliance with prescribed protocols is a well-recognized problem that renders
this method
ineffective. CPT effectiveness is also highly technique sensitive and degrades
as the giver
becomes tired. The requirement that a second person be available to perform
the therapy
severely limits the independence of the CF patient.
[0006] Persons confined to beds and chairs having adverse respiratory
conditions, such as CF
and airway clearance therapy, are treated with pressure pulsating devices that
subject the
person's thorax with high frequency pressure pulses to assist the lung
breathing functions and
blood circulation. The pressure pulsating devices are operatively coupled to
thoracic therapy
garments adapted to be worn around the person's upper body. In hospital,
medical clinic, and
home care applications patients require easy application and low cost
disposable thoracic
garments connectable to portable air pressure pulsating devices that can be
selectively located
adjacent the left or right side of the patients.
[0007]Artificial respiration devices for applying and relieving pressure on
the chest of a
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person have been used to assist in lung breathing functions, and loosening and
eliminating
mucus from the lungs of CF persons. Subjecting the person's chest and lungs to
pressure
pulses or vibrations decreases the viscosity of lung and air passage mucus,
thereby enhancing
fluid mobility and removal from the lungs. An example of a body pulsating
method and device
disclosed by C.N. Hansen in U.S. Patent No. 6,547,749 has a case accommodating
an air
pressure and pulse generator. A handle pivotally mounted on the case is used
as a hand grip to
facilitate transport of the generator. The case including the generator must
be carried by a
person to different locations to provide treatment to individuals in need of
respiratory therapy.
These devices use vests having air-accommodating bladders that surround the
chests of
persons. An example of a vest used with a body pulsating device is disclosed
by C.N. Hansen
and L.J. Helgeson in U.S. Patent No. 6,676,614. The vest is used with an air
pressure and pulse
generator. Mechanical mechanisms, such as solenoid or motor-operating air
valves, bellows
and pistons are disclosed in the prior art to supply air under pressure to
diaphragms and
bladders in regular patterns or pulses. Manually operated controls are used to
adjust the
pressure of the air and air pulse frequency for each patient treatment and
during the treatment.
The bladder worn around the thorax of the CF person repeatedly compresses and
releases the
thorax at frequencies as high as 25 cycles per second. Each compression
produces a rush of air
through the lobes of the lungs that shears the secretions from the sides of
the airways and
propels them toward the mouth where they can be removed by normal coughing.
Examples of
chest compression medical devices are disclosed in the following U.S. Patents.
[0008] Wi Warwick and L.G. Hansen in U.S. Patent Nos. 4,838,263 and 5,056,505
disclose a
chest compression apparatus having a. chest vest surrounding a persons's
chest. A motor-driven
rotary valve located in a housing located on a table allows air to flow into
the vest and vent air
therefrom to apply pressurized pulses to the person's chest. An alternative
pulse
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pumping system has a pair of bellows connected to a crankshaft with rods
operated with a dc
electric motor. The speed of the motor is regulated with a controller to
control the frequency
of the pressure pulses applied to the vest. The patient controls the pressure
of the air in the
vest by opening and closing the end of an air vent tube. The apparatus must be
carried by a
5 person to different locations to provide treatment to persons in need of
respiratory therapy.
[0009] M Gelfand in U.S. Patent No. 5,769,800 discloses a vest design for a
cardiopulmonary resuscitation system having a pneumatic control unit equipped
with wheels
to allow the control unit to be moved along a support surface.
[0010] N.P. Van Brunt and D.J. Gagne in U.S. Patent Nos. 5,769,797 and
6,036,662 disclose
an oscillatory chest compression device having an air pulse generator
including a wall with
an air chamber and a diaphragm mounted on the wall and exposed to the air
chamber. A rod
pivotally connected to the diaphragm and rotatably connected to a crankshaft
transmits force
to the diaphragm during rotation of the crankshaft. An electric motor drives
the crankshaft at
selected controlled speeds to regulate the frequency of the air pulses
generated by the moving
diaphragm. A blower delivers air to the air chamber to maintain the pressure
of the air in the
chamber. Controls for the motors that move the diaphragm and rotate the blower
are
responsive to the air pressure pulses and pressure of the air in the air
chamber. These
controls have air pulse and air pressure responsive feedback systems that
regulate the
operating speeds of the motors to control the pulse frequency and air pressure
in the vest.
The air pulse generator is a mobile unit having a handle and a pair of wheels.
SUMMARY OF THE INVENTION
[0011] The invention is a medical device used to deliver high-frequency chest
wall
oscillations to promote airway clearance and improve bronchial drainage in
humans. The
primary components of the device include an air-pulse generator, an air
inflatable thoracic
garment, and a flexible hose coupling the air-pulse generator to the thoracic
garment for
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transmitting air pressure and pressure pulses from the generator to the
thoracic garment. The
air-pulse generator is mounted on a portable pedestal having wheels that allow
the generator
to be moved to different locations to provide therapy treatments to a number
of persons. The
portable pedestal allows the air-pulse generator to be located adjacent
opposite sides of a
person confined to a bed or chair. The pedestal includes a linear lift that
allows the elevation
or height of the air-pulse generator to be adjusted to accommodate different
locations and
persons. The air-pulse generator includes a housing supporting generator
controls for
convenient use. The housing has a top handle used to manually transport the
air-pulse
generator. The housing is supported on and secured to a frame assembly joined
to the top of
the pedestal. The frame assembly has parallel horizontal members connected to
a platform
engaging the bottom of the housing of the air-pulse generator. Upright members
joined to the
horizontal members are fastened to opposite sides of the housing of the air-
pulse generator.
U-shaped handles joined to and extended outwardly from the upright members
provide
handles to facilitate movement of the pedestal and air-pulse generator.
[0012] The thoracic therapy garment has an elongated flexible body having a
plurality of
elongated generally parallel chambers for accommodating air. An air inlet
connector joined
to a lower portion of the body is releasably coupled to a flexible hose joined
to the air pulse
outlet of the air-pulse generator. One end of the body has hook pads secured
to opposite
sides of the end to allow the garment to be selectively placed around a
person's thorax in ,
clockwise and counterclockwise positions. The outside surface to the body has
a loop texture
that coacts with the loop pads to retain the garment firmly around the
person's thorax. The
thoracic therapy garment is reversible with a single air inlet connector that
can be accessed
from either side of a person's bed or chair. The upper portions of the body
have concave arm
contours that allow the body to cover upper thorax areas.
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DESCRIPTION OF DRAWING
[0013] Figure 1 is a perspective view of a thoracic therapy garment located
around the thorax
of a person connected with a hose to a pedestal mounted air-pulse generator
located on the
left side of the person;
Figure 2 is a perspective view of the thoracic therapy garment of Figure 1
located
around the thorax of a person connected with a hose to a pedestal mounted air-
pulse
generator located on the right side of the person;
Figure 3 is a front elevational view, partly sectioned, of the thoracic
therapy garment
of Figure 1 located around the thorax of a person;
Figure 4 is an enlarged sectional view of the right side of the person of
Figure 3 with
the thoracic therapy garment applying pressure pulses to the person's thorax;
Figure 5 is a linear front elevational view of the thoracic therapy garment of
Figure 1;
Figure 6 is a linear rear elevational view of the thoracic therapy garment of
Figure 1;
Figure 7 is an enlarged sectional view taken along the line 7-7 of Figure 5;
Figure 8 is an enlarged sectional view taken along the line 8-8 of Figure 5;
Figure 9 is an enlarged elevational view, partly sectioned, showing the air
pulse inlet
section of the thoracic therapy garment of Figure 1; and
Figure 10 is an enlarged sectional view taken along the line 10-10 of Figure
5.
DESCRIPTION OF INVENTION
[0014] A portable human body pulsating apparatus 10, shown in Figures 1 and 2,
comprises
an air-pulse generator 11 having a housing 12. A movable pedestal 29 supports
generator 11
and housing 12 on a surface, such as a floor. Pedestal 29 allows respiratory
therapists and
patient careperson to transport the entire human body pulsating apparatus to
different
locations accommodating a number of persons in need of respiratory therapy and
to storage
locations.
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[0015] Human body pulsating apparatus 10 is used with a thoracic therapy
garment 30 to
apply repetitive pressure pulse to a person's thorax to provide secretion and
mucous clearance
therapy. Respiratory mucous clearance is applicable to many medical
conditions, such as
pertussis, cystic fibrosis, atelectasis, bronchiectasis, cavitating lung
disease, vitamin A
deficiency, chronic obstructive pulmonary disease, asthma, and immobile cilia
syndrome.
Post surgical patients, paralyzed persons, and newborns with respiratory
distress syndrome
have reduced mucociliary transport. Apparatus 10 provides high frequency chest
wall
oscillations or pulses to enhance mucus and airway clearance in a person with
reduced
mucociliary transport. High frequency pressure pulses subject to the thorax in
addition to
providing respiratory therapy to a person's lungs and trachea, also stimulates
the heart and
blood flow in arteries and veins in the chest cavity. Muscular and nerve
tensions are also
relieved by the repetitive pressure pulses imparted to the front, sides, and
back portions of the
thorax. The lower part of the thoracic cage comprises the abdominal cavity
which reaches
upward as high as the lower tip of the sternum so as to afford considerable
protection to the
large and easily injured abdominal organs, such as the liver, spleen, stomach,
and kidneys.
The abdominal cavity is only subjected to very little high frequency pressure
pulses.
[0016] Housing 12 is a generally rectangular member having a front wall 13 and
side walls
26 and 27 joined to a top wall 16. An arched member 17 having a horizontal
handle 18
extended over top wall 16 is joined to opposite portions of top wall 16
whereby handle 18 can
be used to manually carry air-pulse generator 11 and facilitate mounting air-
pulse generator
11 on pedestal 29. A control panel 23 mounted on top wall 16 has time coated
keys and
frequency control keys located on opposite sides of a visual control screen.
An air pressure
control knob 24 is located on the left side of panel 23. The control keys,
screen and air
pressure control knob are in locations that are readily accessible by the
respiratory therapists
and user of apparatus 10. The operating elements and functions and controls of
air-pulse
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generator 11 are disclosed by C.N. Hansen, P.E. Cross and L.T. Helgeson in
U.S. Patent
Application No. 2005/0235988. Alternative air pulse generators are disclose by
C.N. Hansen in
US. Patents Nos. 6,488,641 and 6,547,749.
Person care homes, assisted living facilities and clinics can accommodate a
number of persons
in different rooms or locations that require respiratory therapy or high
frequency chest wall
oscillations as medical treatments. The portable pulsating apparatus 10 can be
manually moved
to required locations and connect with a flexible hose 61 to a thoracic
therapy garment 30
located around a person's thorax_ As shown in Figures 1 and 2, pulsating
apparatus 10 can be
selectively located adjacent the left or right side of a person 60 who may be
confined to a bed
or chair.
[0017] Pedestal 29 has an upright gas operated piston and cylinder assembly 31
mounted on a
base 32 having outwardly extended legs 33, 34, 35, 36 and 37. Other types of
linear
expandable and contractible devices can be used to change the location of
generator 11. Caster
wheels 38 are pivotally mounted on the outer ends of legs 33-37 to facilitate
movement of body
pulsating apparatus 10 along a support surface. One or more wheels 38 are
provided with
releasable brakes to hold apparatus 10 in a fixed location. An example of a
pedestal is
disclosed in U.S. Patent No. 5,366,275. The piston and cylinder assembly 31 is
linearly
extendable to elevate air-pulse generator 11 to a height convenient to the
respiratory therapist
or user. A gas control valve having a foot operated ring lever 39 is used to
regulate the linear
extension of piston and cylinder assembly 31 and resultant elevation of
generator 11.
Generator 1 I can be located in positions between its up and down positions.
Lever 39 and gas
control valve are operatively associated with the lower end of piston and
cylinder assembly 31.
[0018] A frame assembly 41 having parallel horizontal members 42 and 43 and a
platform 44
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mounts housing 12 on top of upright piston and cylinder assembly 31. The upper
member of
piston and cylinder assembly 31 is secured to the middle of platform 44. The
opposite ends
46 of platform 44 are turned down over horizontal members 42 and 43 and
secured thereto
with fasteners 48. Upright inverted U-shaped arms 51 and 52 joined to opposite
ends of
horizontal members 42 and 43 are located adjacent opposite side walls 26 and
27 of housing
12. U-shaped handles 56 and 57 are joined to and extend outwardly from arms 51
and 52
provide hand grips to facilitate manual movement of the air-pulse generator 11
and pedestal
29 on a floor or carpet. An electrical female receptacle 58 mounted on side
wall 27 faces the
area surrounded by arm 51 so that arm 51 protects the male plug (not shown)
that fits into
receptacle 58 to provide electric power to air-pulse generator 11. A tubular
air outlet sleeve
is mounted on side wall 26 of housing 12. Hose 61 leading to thoracic therapy
garment 30
telescopes into the sleeve to allow air and air pressure pulses to travel
through hose 61 to
thoracic therapy garment 30 to apply pressure pulses to a person's body.
[0019] Thoracic therapy garment 30, shown in Figure 3, is located around the
person's thorax
69 in substantial surface contact with the entire circumference of thorax 69.
Thoracic therapy
garment 30 functions to apply repeated high frequency compression or pressure
pulses,
shown by arrows 71 and 72, to the person's lungs 66 and 67 and trachea 68. The
reaction of
lungs 66 and 67 and trachea 68 to the pressure pulses causes repetitive
expansion and
contraction of the lung tissue resulting in secretions and mucus clearance
therapy. The
thoracic cavity occupies only the upper part of the thoracic cage which
contains lungs 66 and
67, heart 62, arteries 63 and 64, and rib cage 70. The high frequency pressure
pulses applied
to thorax 69 stimulates heart 62 and blood flow in arteries 63 and 64 and
veins in the chest
cavity. Rib cage 70 also aids in the distribution of the pressure pulses to
lungs 66 and 67 and
trachea 68.
[0020] As shown in Figures 5 and 6, thoracic therapy garment 30 comprises an
elongated
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generally rectangular body 73 including an end flap 74. Body 73, shown in
Figures 7 and 8,
has an inner air impervious flexible member 76 attached to a loop-type fabric
member 77.
The entire outer surface of member 76 is covered with the loop-type fabric
member. The
loop fibers can be embedded or fixed into member 76. Member 76 is a flexible
plastic layer,
such as air impervious urethane plastic. Other types of plastics and materials
can be used for
air impervious member 76. Returning to Figures 5 and 6, body 73 has a
longitudinal bottom
seam or seal 78 and longitudinal middle seams or seals 79 and 81 which form
three
longitudinal chambers 82, 83 and 84 for accommodating air. Seams 78, 79 and 81
are linear
sonic welds. Heat seals can be used for seams 78, 79 and 81. End 86 of body 73
opposite
end 74 has longitudinal seams or seals 87 and 88 longitudinally aligned with
seams 79 and 81
which provide air chambers 89, 90 and 91 for air. Seams 79 and 87 and seams 81
and 88 are
spaced apart. A diagonal seam or seal 92 extends downwardly from top edge 93
of body 73
to about the middle of body 73. Seam 92, as shown in Figure 9, is a divider
that separates the
flow of air shown by arrows 94 and 96 and directs the flow of air into
chambers 82, 83, 84,
89, 90 and 91. An air inlet connector 97 secured to the bottom portion of
member 76 and
seam 78 is adapted to be releasably attached to hose 61. Air flows through
connector 97 into
body 73. Connector 97 is a tubular member joined to a flange 98 secured to
body 73. Other
types of hose connectors can be used to accommodate hose 61 and direct air and
air pressure
pulses into body 73. As shown in Figures 1 and 2, connector 97 is coupled to
hose 61 when
thoracic therapy garment 30 is located clockwise and counterclockwise around
the person's
thorax. The same connector 97 is coupled to hose 61 when thoracic therapy
garment 30 is in
reversed use.
[0021] Returning to Figures 5, 6 and 8, top edge 93 of body 73 has a pair of
concave sections
99 and 101 providing recesses or arm contours that increase coverage of the
upper thoracic
area of the person. The side walls of body 73 below concave sections 99 and
101 have a
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number of small holes 102-107 for allowing a controlled flow of air from
chambers 82, 83
and 84. As shown in Figure 8, holes 105-107 are open to opposite sides of
chambers 82, 83
and 84 to allow air to flow to atmosphere. Air-pulse generator 11 supplies air
and air
pressure pulses to chambers 82, 83 and 84 and maintains a selected air
pressure in chambers
82-84.
[0022] As shown in Figure 10, a first pair of hook pads 108 and 109 are
secured with stitches
111 to opposite sides of end section 74 of body 73. Hoop pads 108 and 109,
shown in
Figures 5 and 6, are diagonal generally rectangular releasable fasteners. A
second pair of
hook pads 112 and 113 are secured with stitches 114 to opposite sides of end
section 74 of
body 73. Hook pads 108, 109, 112 and 113 can be fastened to opposite sides of
end section
74 of body 73 with seams, such as sonic welds or heat seals. In use, hook pads
108 and 109
releasably engage the loop fabric to retain thoracic therapy garment 30
clockwise around the
person's thorax. Hook pads 112 and 113 releasably engage the loop fabric when
body 73 is
reversed to retain thoracic therapy garment 30 counterclockwise around the
person's thorax.
[0023] There has been shown and described an embodiment of a portable air-
pulse generator
connected to a thoracic therapy garment for applying high frequency pressure
pulses to a
person's thorax. Changes in the structure, materials and arrangement of
structure can be
made by persons skilled in the area without departing from the invention.
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